Trial Outcomes & Findings for Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy (NCT NCT04300231)
NCT ID: NCT04300231
Last Updated: 2025-02-10
Results Overview
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
160 participants
Primary outcome timeframe
Pain scores will be measured 48 hours after surgery
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Thoracic Epidural
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
37
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
0
|
2
|
Reasons for withdrawal
| Measure |
Thoracic Epidural
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
3
|
0
|
2
|
Baseline Characteristics
Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
Baseline characteristics by cohort
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=99 Participants
|
70 years
n=107 Participants
|
70 years
n=206 Participants
|
76 years
n=7 Participants
|
72 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
111 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
151 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Body Mass Index (BMI) inkg/m^2
|
28.5 kg/m^2
n=99 Participants
|
27.7 kg/m^2
n=107 Participants
|
27.3 kg/m^2
n=206 Participants
|
26.8 kg/m^2
n=7 Participants
|
27.6 kg/m^2
n=31 Participants
|
|
Duration of Surgery-in minutes
|
305 minutes
n=99 Participants
|
280.5 minutes
n=107 Participants
|
285.0 minutes
n=206 Participants
|
295.0 minutes
n=7 Participants
|
291.4 minutes
n=31 Participants
|
PRIMARY outcome
Timeframe: Pain scores will be measured 48 hours after surgeryPopulation: 48-hour Pain Scores
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
VAS Score at 48 Hour
48-hour Pain Scores at Movement
|
5 score on a scale
Interval 1.5 to 7.5
|
7 score on a scale
Interval 4.0 to 8.0
|
4 score on a scale
Interval 4.0 to 8.0
|
6 score on a scale
Interval 4.0 to 9.0
|
|
VAS Score at 48 Hour
48-hour Pain Scores at Rest
|
2 score on a scale
Interval 0.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 0.0 to 4.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 72 hours after surgeryPopulation: Pain Scores at 72 hour
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
VAS Score at 72 Hour
72-hour Pain Scores at Movement
|
3.5 score on a scale
Interval 1.0 to 5.5
|
3 score on a scale
Interval 2.0 to 5.0
|
5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 2.0 to 5.0
|
|
VAS Score at 72 Hour
72-hour Pain Scores at Rest
|
1 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 0.0 to 4.0
|
3 score on a scale
Interval 1.0 to 6.0
|
2 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Opioid comsumption will be measured at 1 hourPopulation: 1-hour opioid consumption
Opioid consumption will be collected by a study team member post operatively at hour 1 per protocol time requirements
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose
|
5.7 milligram morphine equivalents
Interval 0.0 to 45.0
|
6.5 milligram morphine equivalents
Interval 0.0 to 36.0
|
5.8 milligram morphine equivalents
Interval 0.0 to 40.0
|
4.1 milligram morphine equivalents
Interval 0.0 to 42.0
|
SECONDARY outcome
Timeframe: Opioid comsumption will be measured at 24 hoursPopulation: Opioid consumption at 24-hour
Opioid consumption will be collected by a study team member post operatively at hour 24 per protocol time requirements
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose
|
19 milligram morphine equivalents
Interval 12.2 to 39.1
|
36 milligram morphine equivalents
Interval 20.0 to 60.0
|
52 milligram morphine equivalents
Interval 36.0 to 78.0
|
30 milligram morphine equivalents
Interval 16.0 to 60.0
|
SECONDARY outcome
Timeframe: Opioid comsumption will be measured at 48 hoursPopulation: Opioid consumption at 48 hour
Opioid consumption will be collected by a study team member post operatively at hour 48 per protocol time requirements
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose
|
24.8 milligram morphine equivalents
Interval 16.9 to 33.3
|
28 milligram morphine equivalents
Interval 16.0 to 48.0
|
52 milligram morphine equivalents
Interval 24.0 to 84.0
|
44 milligram morphine equivalents
Interval 20.0 to 96.0
|
SECONDARY outcome
Timeframe: Opioid comsumption will be measured at 72 hoursPopulation: Opioid consumption at 72 hour
Opioid consumption will be collected by a study team member post operatively at hour 72 per protocol time requirements
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose
|
26.7 milligram morphine equivalents
Interval 17.8 to 36.5
|
32 milligram morphine equivalents
Interval 20.0 to 44.0
|
40 milligram morphine equivalents
Interval 24.0 to 72.0
|
32 milligram morphine equivalents
Interval 19.0 to 64.0
|
SECONDARY outcome
Timeframe: Opioid comsumption will be measured at 96 hoursPopulation: Opioid consumption at 96 hour
Opioid consumption will be collected by a study team member post operatively at hour 96 per protocol time requirements
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose
|
21.1 milligram morphine equivalents
Interval 9.8 to 34.5
|
33 milligram morphine equivalents
Interval 15.0 to 55.5
|
23.3 milligram morphine equivalents
Interval 12.0 to 48.0
|
20 milligram morphine equivalents
Interval 8.0 to 56.0
|
SECONDARY outcome
Timeframe: Pain scores will be measured 1 hour after surgeryPopulation: 1-hour pain scores
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
VAS Score at 1 Hour
1-hour pain scores at movement
|
4.4 score on a scale
Interval 0.0 to 10.0
|
3.1 score on a scale
Interval 0.0 to 10.0
|
2.9 score on a scale
Interval 0.0 to 10.0
|
2.3 score on a scale
Interval 0.0 to 7.0
|
|
VAS Score at 1 Hour
1-hour pain scores ar rest
|
3.6 score on a scale
Interval 0.0 to 10.0
|
3.5 score on a scale
Interval 0.0 to 10.0
|
2.7 score on a scale
Interval 0.0 to 10.0
|
1.9 score on a scale
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Pain scores will be measured 24 hours after surgeryPopulation: 24-hour Pain Scores
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
VAS Score at 24
24- hour pain score at movement
|
5 score on a scale
Interval 1.5 to 7.5
|
7 score on a scale
Interval 4.0 to 8.0
|
5 score on a scale
Interval 4.0 to 8.0
|
6 score on a scale
Interval 4.0 to 9.0
|
|
VAS Score at 24
24-hour pain score at rest
|
2 score on a scale
Interval 0.0 to 5.0
|
3 score on a scale
Interval 2.0 to 6.0
|
3 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Pain scores will be measured 96 hours after surgeryPopulation: 96-hour pain scores
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
VAS Score at 96 Hour
96-hour pain score at rest
|
2 score on a scale
Interval 0.0 to 4.0
|
2 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
|
VAS Score at 96 Hour
96-hour pain score at movement
|
4.5 score on a scale
Interval 2.0 to 5.5
|
3 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 1.0 to 6.0
|
3 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 1 hourPopulation: 1-hour nausea score
Nausea scores will be collected by study team member post operatively at hour 1 per protocol. Result is reported as nausea or no nausea.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Nausea at 1 Hour
|
4 participants
|
5 participants
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 24 hourPopulation: 24-hour nausea score
Nausea scores will be collected by study team member post operatively at hour 24 per protocol. Result is reported as nausea or no nausea.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Nausea at 24 Hours
|
9 participants
|
5 participants
|
7 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 48 hourPopulation: 48-hour nausea score
Nausea scores will be collected by study team member post operatively at hour 48 per protocol. Result is reported as nausea or no nausea.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Nausea at 48 Hours
|
11 participants
|
11 participants
|
10 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 72 hourPopulation: 72-hour nausea score
Nausea scores will be collected by study team member post operatively at hour 72 per protocol. Result is reported as nausea or no nausea.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Nausea at 72 Hours
|
11 participants
|
12 participants
|
17 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 96 hourPopulation: 96-hour nausea score
Nausea scores will be collected by study team member post operatively at hour 96 per protocol. Result is reported as nausea or no nausea.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Nausea at 96 Hours
|
15 participants
|
6 participants
|
12 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 1 hourPopulation: 1hr sedation score
Sedation scores will be collected by a study team member post operatively at hour 1. Results are interpreted as patient with or without any sedation.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Sedation at 1 Hour
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 24 hourPopulation: 24-hour sedation score
Sedation scores will be collected by a study team member post operatively at hour 24. Results are interpreted as patient with or without any sedation.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Sedation at 24 Hours
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 hourPopulation: 48-hour sedation score
Sedation scores will be collected by a study team member post operatively at hour 48. Results are interpreted as patient with or without any sedation.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Sedation at 48 Hours
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 72 hourPopulation: 72-hour sedation score
Sedation scores will be collected by a study team member post operatively at hour 72. Results are interpreted as patient with or without any sedation.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Sedation at 72 Hours
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 96 hourPopulation: 96-hour sedation score
Sedation scores will be collected by a study team member post operatively at hour 96. Results are interpreted as patient with or without any sedation.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Number of Participants With Sedation at 96 Hours
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Assess daily until patient passes gas postoperatively, up to 120 hours after surgeryPopulation: Time to first Flatus
The first time the patients passes gas post operatively.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
First Flatus-bowel Movement
|
70.3 Hours
Interval 42.8 to 89.6
|
55.5 Hours
Interval 34.5 to 84.0
|
69.7 Hours
Interval 56.2 to 96.7
|
59.8 Hours
Interval 37.7 to 78.4
|
SECONDARY outcome
Timeframe: Creatinine level will be collected daily postoperatively for 4 daysPopulation: creatinine level Postoperatively
Lab level of Creatinine will be recorded for 4 days post operatively.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Postoperative Creatinine
|
1.0 mg/dL
Interval 0.8 to 1.38
|
0.98 mg/dL
Interval 0.79 to 1.25
|
1.08 mg/dL
Interval 0.79 to 1.46
|
0.96 mg/dL
Interval 0.78 to 1.28
|
SECONDARY outcome
Timeframe: From hospital admission to discharge timePopulation: Length of Stay (LOS)
Length of Stay will be collected from Cerner Electronic Medical Record. Pt. followed for length of stay, up till 4 weeks after surgery.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Time to Discharge-Length of Stay
|
7.1 days
Interval 6.1 to 8.9
|
6.0 days
Interval 5.1 to 7.1
|
6.4 days
Interval 5.3 to 8.2
|
7.0 days
Interval 6.1 to 9.1
|
SECONDARY outcome
Timeframe: number of times hypotension occurred the first 96 hours after surgery.Population: cumulative number of hypotension episodes in 96 hours
Defined as BP decrease of more than 20% from baseline. The reported number for each arm is the cumulative number of hypotension episodes experienced in each arm.
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Incidence of Hypotension
|
25 hypotension episodes
|
22 hypotension episodes
|
16 hypotension episodes
|
26 hypotension episodes
|
SECONDARY outcome
Timeframe: assess daily as yes/no up to 96hrPopulation: Incidence of Respiratory Depression
Define by use of Narcan
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Incidence of Respiratory Depression
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Patients followed for ambulation activities on postop Day 1 and Day 2Population: Ambulation activity
Number of participants who got out of bed and is ambulatory on Postoperative Day 1 and postoperative Day 2
Outcome measures
| Measure |
Thoracic Epidural
n=36 Participants
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=37 Participants
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 Participants
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=38 Participants
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Ambulation Activity Postoperatively
Patient Starts ambulating on Day 1-Yes
|
34 Participants
|
35 Participants
|
38 Participants
|
36 Participants
|
|
Ambulation Activity Postoperatively
Patient starts ambulating on Day 2-yes
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Thoracic Epidural
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rectus Sheath Block
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Surgeon Infiltration With Liposomal Bupivacaine (LB)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Surgeon Infiltration
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thoracic Epidural
n=40 participants at risk
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
|
Rectus Sheath Block
n=40 participants at risk
2\. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration With Liposomal Bupivacaine (LB)
n=40 participants at risk
3\. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
|
Surgeon Infiltration
n=40 participants at risk
4\. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
bupivacaine 0.5%: 60 mL
injectable saline: 40 mL
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/40 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
5.0%
2/40 • Number of events 4 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
17.5%
7/40 • Number of events 8 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
5.0%
2/40 • Number of events 2 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
|
Respiratory, thoracic and mediastinal disorders
respiratory depression
|
0.00%
0/40 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
5.0%
2/40 • Number of events 2 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
2.5%
1/40 • Number of events 1 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
0.00%
0/40 • Adverse events were collected for up to 3 weeks of hospitalization stay
|
Additional Information
Yar Luan Yeap, MD
Indiana University Department of Anesthesiology
Phone: 317-274-0275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place